Pharmaceutical and Biotech manufacturing operations are increasingly adopting single use systems to lower the cost of manufacturing. The traditional process of manufacturing products is in stainless steel vessels with hard piping. This process is expensive to install, difficult to reconfigure, expensive to clean, and requires significant effort to validate the sterility status of the equipment. Single-Use systems have changed this. Single-Use systems offer lower total cost due to: less space needed on the manufacturing floor, reduced capital expense on dedicated equipment, elimination of costly CIP (Clean in Place) and SIP (Steam in Place) systems, reduced labor in sterility verification, and decreased time between batches due to the elimination of the these cleaning/testing steps. Additionally, there is an environmental advantage with single-use systems; namely, the elimination of harsh CIP chemicals and their disposal, the elimination of the cost associated with steam generation for SIP processes, and a reduction in the demand for WFI (water for injection). Studies have shown that single-use systems have a lower overall environmental footprint than traditional stainless steel systems.
The drawback of such single-use systems is the need to properly connect numerous sensor wires and ingredient feed and discharge lines to one or more disposable main processing containers. The connections must be made accurately in order insure the integrity of the production process. However, the single-use nature of the equipment mandates that the cost for automatic verification be kept to a minimum.
Verification of connections in industrial processing equipment has been known through the use of RFID ‘go-no-go’ connections. Colder Products IdentiQuik Series Smart Couplings with RFID is one example of a system having a separate RFID reader built into one half of the connector. The results in increased size, and also increases the expense of the connectors due to the need for multiple expensive readers, which would need to be re-used. This is impractical for use in many applications, particularly in consideration of the single-use system becoming popular. With this known system, either the connector half having the RFID reader must be cleaned and/or sterilized after each use in order to make it economical, which does not lend itself to the single-use system concept, or the entire connection would need to be disposable, resulting in high cost due to the readers needing to be replaced after each use.
The current process for checking connections in single use systems includes: Paper log books, production check off lists, SOPs and visual inspections which can be prone to error. Drawbacks are that transcription errors can be made in paper log books or production check off lists. Additionally, log books, SOPs, check off lists, etc. are single point in time verifications. If, for example, sensors or lines are disconnected and reconnected incorrectly after the initial hook-up and check, there is no reliable way to re-check and/or ensure the integrity of the processes being carried out
It would be desirable to provide a monitoring system where these errors can be minimized, if not eliminated.